FDA Adverse Event
Injury
Summary report: N
TRANSVENOUS
MDR report key: 1944844
·
Received January 3, 2011
Report
- Report Number
- 2124215-2010-19376
- Event Type
- Injury
- Date Received
- January 3, 2011
- Date of Event
- October 1, 2010
- Report Date
- October 1, 2010
- Manufacturer
- CPI - DEL CARIBE
- Product Code
- NVN
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Additional Manufacturer Narrative · 1
THE LEAD WAS SURGICALLY ABANDONED AND SUCCESSFULLY REPLACED.
Description of Event or Problem · 1
BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THIS RIGHT ATRIAL (RA) LEAD HAD A LEAD SAFETY SWITCH AS WELL AS NOISE. IT IS UNKNOWN IF THIS WAS DUE TO HIGH OR LOW IMPEDANCE MEASUREMENTS. THERE WAS ALSO SOME SENSING FLUCTUATIONS NOTED IN THE DAILY MEASUREMENTS. DURING A RECENT DEVICE CHANGE OUT PROCEDURE, THE PHYSICIAN FOUND THE LEAD TO BE FRACTURED AND ELECTED TO SURGICALLY ABANDON THE LEAD AND REPLACE IT. TO DATE, THERE HAVE BEEN NO ADVERSE PATIENT EFFECTS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TRANSVENOUS | IMPLANTABLE LEAD | NVN | CPI - DEL CARIBE | 4271 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 79 YR | Other| R | 4285| 1230| 4271| 1298 |